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Found 4 results
510(k) Data Aggregation
K Number
K041980Device Name
MSI S-500L RF GENERATOR
Manufacturer
Date Cleared
2004-08-06
(14 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDSPHERE INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Device Description
MSI S-500L RF Generator
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K Number
K033888Device Name
MSI MODEL S-500 RF GENERATOR
Manufacturer
Date Cleared
2004-04-02
(108 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDSPHERE INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Device Description
MSI S-500 RF Generator
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K Number
K030996Device Name
MSI SA ELECTRODES
Manufacturer
Date Cleared
2003-05-30
(60 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDSPHERE INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Device Description
The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.
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K Number
K024266Device Name
MSI TA ELECTRODES
Manufacturer
Date Cleared
2003-03-12
(79 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
MEDSPHERE INTERNATIONAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Indicated for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Device Description
Not Found
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